Pneumococcal DiseasePhase 2NCT06531538
A Study to Learn About How a New Pneumococcal Vaccine Works in Children
A Phase 2 study testing PG4 and 20-valent pneumococcal conjugate vaccine (20vPnC) in people with Pneumococcal Disease, run by Pfizer at 39 sites in 2 countries.
Trial summary
The purpose of this study is to learn about the safety, tolerability and immune effects of a pneumococcal vaccine in toddlers. Participants will take part in this study for approximately 6 or 8 months depending on which group they are assigned to. Read more about this study
- Who is it for?
- Ages 12 to 15 monthsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Disease
- What is being tested?
- PG4 and 20-valent pneumococcal conjugate vaccine (20vPnC)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 39 sitesin 2 countries
- Study dates
- 30 Jul 2024to 9 Feb 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female toddlers ≥12 to ≤15 months of age at the time of consent.
- Healthy toddlers determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
- Have received 3 infant doses of 20vPnC with the last dose administered >56 days before enrollment into the study. Documented confirmation of receipt will be collected prior to randomization.
Who cannot join
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis).
- Major known congenital malformation or serious chronic disorder.
- Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- Previous vaccination with any licensed or investigational pneumococcal vaccine (other than 20vPnC) or planned receipt during study participation.
Trial locations and contacts
39 sites in 2 countries.
39 sites in 2 countries
United States35 sites
The Iowa Clinic
Ankeny, Iowa, 50023
University of Maryland, Baltimore - Institutional Review Board
Baltimore, Maryland, 21201
University of Maryland, Baltimore, Center for Vaccine Development and Global Health
Baltimore, Maryland, 21201
Tekton Research, LLC.
Chamblee, Georgia, 30341
Carolina Family Care
Charleston, South Carolina, 29414
MUSC Children's Health
Charleston, South Carolina, 29414
Atrium Health - Strive Vaccine Research Clinic
Charlotte, North Carolina, 28207
Atrium Health-Myers Park
Charlotte, North Carolina, 28207
The Pediatric Center
Columbia, Maryland, 21045
Javara - Privia Medical Group North Texas - Dallas
Dallas, Texas, 75230
Oak Cliff Research Company, LLC
Dallas, Texas, 75252
Oak Cliff Research Company, LLC
Dallas, Texas, 75287
Duke Vaccine and Trials Unit
Durham, North Carolina, 27703
Durham Pediatrics at North Duke Street
Durham, North Carolina, 27704
Duke University
Durham, North Carolina, 27705
Javara - Privia Medical Group Georgia - Fayetteville
Fayetteville, Georgia, 30214
Mercury Clinical Research - Houston
Houston, Texas, 77054
DM Clinical Research - Kool Kids Pediatrics
Houston, Texas, 77065
Kool Kids Pediatrics
Houston, Texas, 77065
Mercury Clinical Research - Sunrise Pediatrics
Houston, Texas, 77077
Mercury Clinical Research - Pediatric Associates
Houston, Texas, 77087
Holston Medical Group
Kingsport, Tennessee, 37660
University of Texas Medical Branch
League City, Texas, 77573
Atrium Health-Matthews
Matthews, North Carolina, 28105
Bio-Medical Research LLC
Miami, Florida, 33144
Louisiana State University Health Sciences Shreveport - Fairfield avenue
Shreveport, Louisiana, 71101
Louisiana State University Health Sciences Shreveport
Shreveport, Louisiana, 71103
Ochsner/LSU Health Ambulatory Care Center
Shreveport, Louisiana, 71103
Senders Pediatrics
South Euclid, Ohio, 44121
Carolina Family Care
Summerville, South Carolina, 29486
MUSC Children's Health
Summerville, South Carolina, 29486
Mercury Clinical Research - North Houston Internal Medicine & Pediatric Clinic
Tomball, Texas, 77375
Pediatric Clinical Trials of Tennessee, LLC
Tullahoma, Tennessee, 37388
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, 30291
Emerson Clinical Research Institute
Washington D.C., District of Columbia, 20009
Puerto Rico4 sites
Ponce Medical School Foundation Inc.
Ponce, 00716
BRCR Medical Center - Ponce
Ponce, 00717
BRCR Global Puerto Rico
San Juan, 00907-1509
CMRC Headlands, LLC
San Juan, 00918
About this study
Official title: A PHASE 2, RANDOMIZED, PARTIALLY DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE ADMINISTERED IN HEALTHY TODDLERS 12 THROUGH 15 MONTHS OF AGE
The purpose of this study is to learn about the safety, tolerability and immune effects of a pneumococcal vaccine in toddlers.
Participants will take part in this study for approximately 6 or 8 months depending on which group they are assigned to. During this time participants will have 2 clinic visits and 1 phone visit for the 1-Dose group, or 3 clinic visits and 1 phone visit for the 2-Dose group.
At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during some clinic visits.
- Conditions
- Pneumococcal Disease
- Being tested
- PG4, 20-valent pneumococcal conjugate vaccine (20vPnC)
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PG4Biological
Multivalent pneumococcal conjugate vaccine.
20-valent pneumococcal conjugate vaccine (20vPnC)Biological
Also called Prevnar 20
20-valent pneumococcal conjugate vaccine (20vPnC)
| Study group | Role | What they receive |
|---|---|---|
| PG4 1-Dose Group | Experimental | Participants to receive a single injection of Multivalent Pneumococcal Vaccine Receives: Biological: PG4 |
| PG4 2-Dose Group | Experimental | Participants to receive two injections of Multivalent Pneumococcal Vaccine Receives: Biological: PG4 |
| 20-valent pneumococcal conjugate vaccine (20vPnC) | Active comparator | Participants to receive a single injection of 20-valent pneumococcal conjugate vaccine (20vPnC). Receives: Biological: 20-valent pneumococcal conjugate vaccine (20vPnC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants reporting prespecified local reactions within 7 days after each dose
Prespecified local reactions (redness, swelling, and pain at the injection site) after each dose
Measured: 7 days after each dose
Percentage of participants reporting prespecified systemic events within 7 days after each dose
Prespecified systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability) after each dose
Measured: 7 days after each dose
Percentage of participants reporting Adverse Events (AEs) within 1 month after the last assigned vaccination
Adverse events occurring within 1 month after the last assigned vaccination
Measured: From signing of ICD to 1 month after last assigned vaccination
Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination
SAEs occurring from Dose 1 through 6 months after the last assigned vaccination
Measured: From signing of ICD to 6 months after last assigned vaccination
Secondary outcomes (1)
Pneumococcal serotype specific IgG concentrations
Pneumococcal IgG GMCs 1 month after the last assigned vaccination
Measured: 1 month after last assigned vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start30 Jul 2024
- Primary completion9 Feb 2026
- Study completion9 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal DiseaseStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531538
- Sponsor's protocol ID
- C4931010
- Other IDs
- C4931010-OPENLABEL
- Status last verified
- Mar 2026
- First submitted
- 23 Jul 2024
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 2, RANDOMIZED, PARTIALLY DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE ADMINISTERED IN HEALTHY TODDLERS 12 THROUGH 15 MONTHS OF AGE
- ClinicalTrials.gov ID
- NCT06531538
- Acronym / sponsor ID
- C4931010
- Conditions
- Pneumococcal Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 9 Feb 2026 (actual)
- Study completion
- 9 Feb 2026 (actual)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn about the safety, tolerability and immune effects of a pneumococcal vaccine in toddlers.
Participants will take part in this study for approximately 6 or 8 months depending on which group they are assigned to. During this time participants will have 2 clinic visits and 1 phone visit for the 1-Dose group, or 3 clinic visits and 1 phone visit for the 2-Dose group.
At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during some clinic visits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| PG4 1-Dose Group | Experimental | Biological: PG4Participants to receive a single injection of Multivalent Pneumococcal Vaccine |
| PG4 2-Dose Group | Experimental | Biological: PG4Participants to receive two injections of Multivalent Pneumococcal Vaccine |
| 20-valent pneumococcal conjugate vaccine (20vPnC) | Active comparator | Biological: 20-valent pneumococcal conjugate vaccine (20vPnC)Participants to receive a single injection of 20-valent pneumococcal conjugate vaccine (20vPnC). |
Who may qualify
- Ages
- 12 to 15 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male or female toddlers ≥12 to ≤15 months of age at the time of consent.
- Healthy toddlers determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
- Have received 3 infant doses of 20vPnC with the last dose administered >56 days before enrollment into the study. Documented confirmation of receipt will be collected prior to randomization.
Key exclusion criteria (4 listed)
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis).
- Major known congenital malformation or serious chronic disorder.
- Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- Previous vaccination with any licensed or investigational pneumococcal vaccine (other than 20vPnC) or planned receipt during study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PG4Multivalent pneumococcal conjugate vaccine. | Biological | PG4 1-Dose Group, PG4 2-Dose Group |
| 20-valent pneumococcal conjugate vaccine (20vPnC)Also: Prevnar 2020-valent pneumococcal conjugate vaccine (20vPnC) | Biological | 20-valent pneumococcal conjugate vaccine (20vPnC) |
Primary outcome
Percentage of participants reporting prespecified local reactions within 7 days after each dose
Time frame: 7 days after each dose
Prespecified local reactions (redness, swelling, and pain at the injection site) after each dose
Percentage of participants reporting prespecified systemic events within 7 days after each dose
Time frame: 7 days after each dose
Prespecified systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability) after each dose
Percentage of participants reporting Adverse Events (AEs) within 1 month after the last assigned vaccination
Time frame: From signing of ICD to 1 month after last assigned vaccination
Adverse events occurring within 1 month after the last assigned vaccination
Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination
Time frame: From signing of ICD to 6 months after last assigned vaccination
SAEs occurring from Dose 1 through 6 months after the last assigned vaccination
1 secondary outcome
Pneumococcal serotype specific IgG concentrations
Time frame: 1 month after last assigned vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
39 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PG4 and 20-valent pneumococcal conjugate vaccine (20vPnC) in people with Pneumococcal Disease, run by Pfizer at 39 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants reporting prespecified local reactions within 7 days after each dose (time frame: 7 days after each dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.